Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of rad001 in patients aged 18 and over with angiomyolipoma associated with either tuberous sclerosis complex (tsc) or sporadic lymphangioleiomyomatosis (lam)

Conditions: Tuberous Sclerosis Complex (TSC); Lymphangioleiomyomatosis (LAM)

Summary: this study will evaluate the safety and efficacy of rad001 in treating patients with angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis.


Eligibility criteria:
inclusion criteria: * male or female 18 years or older * clinically definite diagnosis of tuberous sclerosis complex according to the modified gomez criteria or sporadic lam (biopsy-proven or compatible chest ct scan) * clinically definite diagnosis of renal angiomyolipoma * at least one angiomyolipoma of ≥ 3 cm in its longest diameter using ct or mri * females of child bearing potential must use birth control and have documentation of negative pregnancy test * written informed consent according to local guidelines exclusion criteria: * recent heart attack, cardiac related chest pain or stroke * severely impaired lung function * bleeding related to angiomyolipoma or embolization during 6 months prior to randomization * clinically significant chylous ascites * clinically significant hematological or hepatic abnormality * severe liver dysfunction * severe kidney dysfunction * pregnancy or breast feeding * current infection * history of organ transplant * surgery within two months prior to study enrollment * prior therapy with a medication in the same class as everolimus * recent use of an investigational drug * bleeding diathesis or on oral anti-vitamin k medication * uncontrolled high cholesterol * uncontrolled diabetes * hiv * inability to attend scheduled clinic visits * patients with metal implants thus prohibiting mri evaluations * angiomyolipoma which requires surgery at the time of randomization * history of malignancy * severe or uncontrolled medical conditions which would cause an unacceptable safety risk or compromise compliance with the protocol

Keywords: angiomyolipoma aml tuberous sclerosis complex tsc mtor rad001 mammalian target of rapamycin everolimus afinitor sega subependymal giant cell astrocytoma seizures tuberous sclerosis complex (tsc) tuberous sclerosis benign tumors of brain kidney heart eyes lungs skintsc1 tsc2 hamaratin tuberin, tumor growth suppressors gyri tubers sporadic lymphangioleiomyomatosis. lymphangioleiomyomatosis (lam) rare lung disease
neuropsychological characterization of patients with bipolar disorder and a history of suicide attempt

Conditions: Bipolar Disorder

Summary: the main objective of this study is to evaluate decision-making using the iowa gambling task (igt) among patients with euthymic bipolar disorder according to their personal history of suicide attempt ("suicidal" vs. "not suicidal ").

the secondary objectives of this study are: a. evaluate other aspects of cognitive functioning (using the tower of london, the probabilistic reversal-learning task, the rey complex figure, the reading the mind in the eyes test) in euthymic patients with bipolar disorder, depending on the presence or absence of a history of suicide attempt; b. explore performance on neuropsychological tests depending on the type of therapy administered (lithium salts or valproate monotherapy or in combination with other mood stabilizers); c. explore a possible relationship between circulating levels of lithium or sodium divalproex results and different neuropsychological tests; d. establishment of a biobank for this population with leftover blood samples following serum lithium or divalproex testing.

Eligibility criteria:
inclusion criteria: * the patient was correctly informed about the study * the patient must be insured or beneficiary of a health insurance plan * the diagnosis of bipolar disorder is confirmed by the doctor referring the patient to the bec and confirmed during the preliminary interview at the bec * the patient is euthymic on the day of inclusion. this is supported by a short psychiatric interview conducted at the bec and the completion of the depression and mania scales (score \<= 7 on the hdrs questionnaire and score \<= 7 on the ymrs questionnaire). * the patient is prescribed a mood stabilizer based on lithium or divalproex. exclusion criteria: * the patient is under judicial protection, under tutorship or curatorship * the patient formalizes his/her opposition to the studyd * it is impossible to correctly inform the patient * the patient has mental retardation * the patient has practiced substance abuse or dependence within the 6 months prior to study inclusion (alcool, cannabis, opiates, psychostimulants) * the patient does not meet euthymic criteria (score \<= 7 on the hdrs questionnaire and score \<= 7 on the ymrs questionnaire). uninclusion criteria: * the patients withdraws consent during the study * the patient does not understand directions necessary for the neurpsychological tasks * the patient is not able to use a computer to complete the neuropsychological tasks

Keywords: suicidal ideation
protect: prospective trial on erythropoietin in clinical transplantation

Conditions: Patients Receiving a Kidney From a Non-Heart-Beating Donor

Summary: randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation. the investigators postulate that erythropoietin reduces the risk of delayed graft function.

randomized, double blind, placebo controlled, prospective trial in patients, receiving a kidney transplantation. patients will be randomized to receive either epoetin beta (neorecormon; roche) or placebo. the primary endpoint will be delayed graft function. the anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.

Eligibility criteria:
inclusion criteria: * adult patients * receiving a kidney from a non-heart-beating donor category 3 exclusion criteria: * donor related factors: a prolonged warm ischaemic time (\> 45 min); a cold ischaemic time of \> 24 hours; serum creatinin of \> 150 umol/l

Keywords: erythropoietin kidney transplantation delayed graft function
impacts of alcohol warning labels: an online experiment

Conditions: Alcohol Drinking

Summary: the goal of this experiment is to examine responses to alcohol warning messages about 10 different topics among us adult alcohol consumers. the main questions this experiment aims to answer are: which warning topics make alcohol consumers in the us want to drink less alcohol? which warning topics remind alcohol consumers in the us of alcohol's harms? which warning topics help alcohol consumers in the us learn something new? there will be a total of 20 alcohol messages, 2 messages for each of the 10 topics. for each topic, participants will be randomly assigned to 1 of the 2 messages so that they view a total of 10 alcohol messages. all 10 messages will be shown in random order. participants will rate each message on how much it makes them want to drink less alcohol, reminds them that drinking can be harmful, and teaches them something new.

this study aims to determine which topics in alcohol warning labels are most effective at making us adults who consume alcohol want to drink less alcohol, which topics best remind consumers of alcohol's harms, and which topics are most likely to teach consumers something new. the survey research company norc at the university of chicago will recruit a sample of 1,000 us adults ages 21+ who consumed alcohol at least one time per week during the past 4 weeks. participants will complete a within-subjects online randomized experiment in which they view and rate messages shown on alcohol containers. participants will rate each message on perceived message effectiveness (primary outcome), reminding of alcohol's harms (secondary outcome), and learning something new (secondary outcome). these tasks will be repeated for 10 messages, each with a different topic. there will be 9 warning topics (i.e., topics about alcohol's harms) and 1 control topic (i.e., neutral topic not about alcohol's harms). in this within-subjects experiment, the survey will present the topics in random order and participants will view 1 of 2 messages for each topic.

Eligibility criteria:
inclusion criteria: * age 21 and older * reside in the united states * able to complete a survey in english * consumed alcohol at least once per week during the past 4 weeks exclusion criteria: * under the age of 21 * reside outside of the united states * unable to complete a survey in english * consumed alcohol less than once per week during the past 4 weeks
internet-delivered cognitive behaviour therapy for sleep problems in asd

Conditions: Autism Spectrum Disorder; Sleep Disturbance; Insomnia

Summary: this trial investigates the behavioural effects of internet-based cognitive behaviour therapy for insomnia (cbt-i) in adolescents with autism spectrum disorder with sleep problems. this is a randomised controlled trial.

sleep problems are common in adolescents with autism spectrum disorder (asd)1. internet-based cognitive behaviour therapy for insomnia (icbt-i) is considered as an evidence-based treatment for insomnia 2. to date, no internet-based cbt-i delivered treatment for sleep problems in adolescents with asd has been undertaken. the objective of the study is to investigate the efficacy and effectiveness of the internet-based cbt-i for sleep problems in adolescents with asd.

Eligibility criteria:
inclusion criteria: * adolescents with a clinical asd diagnosis based on the diagnostic and statistical manual-fifth edition (dsm-5). participants have been investigated with the autism diagnostic observation schedule (ados). * insomnia diagnosis or sleep problems according to dsm-5 * intelligence quotient (iq) \> 70 according to wechsler intelligence scale for children - fourth edition * psychiatric comorbidities according to dsm-5: anxiety disorders or depression. exclusion criteria: * the presence of clinically assessed self-injury * high risk of suicidal behaviour * borderline personality disorder or any form of schizophrenia or related disorders; * substance abuse as well as physical illness or condition that was largely influence sleep condition.

Keywords: autism spectrum disorder sleep cognitive-behavioral treatment internet delivered treatment
identification of the risk of remote pulmonary hypertension in preterm births.

Conditions: PreTerm Neonate; Pulmonary Hypertension of Newborn; Right Ventricular Dysfunction

Summary: this study aims to learn about the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely, at birth and at a distance, and the association with the development of pulmonary bronchodysplasia, so that screening programs can be set up in the future and proper treatment can be initiated in a timely manner.

this study aims to learn about the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely, at birth and at a distance, and the association with the development of pulmonary bronchodysplasia, so that screening programs can be set up in the future and proper treatment can be initiated in a timely manner. enrolled patients, should asymptomatic pulmonary hypertension be diagnosed, will be able to be taken to dedicated outpatient clinics and initiate appropriate treatment if indicated. the primary goal of this study is to evaluate the incidence of late pulmonary arterial hypertension and/or right ventricular dysfunction in a cohort of former preterm patients. the study will also provide a greater awareness of the epidemiology of pulmonary hypertension and right ventricular dysfunction in these patients and allow appropriate screening and follow-up to be planned.

Eligibility criteria:
inclusion criteria: * patients diagnosed with prematurity with gestational age less than 30 weeks evaluated at outpatient clinics dedicated to neonatal follow-up of participating health care providers during the study data collection period. * obtaining informed consent. exclusion criteria: * prenatal or postnatal diagnosis of genetic disease; * concomitant presence of congenital heart disease except interatrial defect or patency of the ductus arteriosus; * concomitant presence of diaphragmatic hernia
the pathogenesis of hepatitis c virus vertical transmission

Conditions: Hepatitis C; Infection Transmission, Maternal-Fetal

Summary: to evaluate for the presence of hcv core protein, hcv rna and spp in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. in parallel, we will assess placental tissue for evidence of hcv infection using a novel in situ hybridization technique and translate our in vitro findings to these in vivo samples. our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the placenta serve as a "barrier" that must be crossed during vertical transmission and that cytotrophoblasts are permissive to hcv at a low level that may be enhanced under certain conditions. by comparing the regulation of key steps in the intracellular life cycle of hcv in cytotrophoblasts to highly permissive hepatocytes, significant differences in hcv regulation should be revealed. based on our preliminary data, our working hypothesis is that hcv core protein is differentially processed in cytotrophoblasts compared to hepatocytes.


Eligibility criteria:
inclusion criteria: * pregnant women with hcv infection * pregnant women without hcv infection exclusion criteria: * none

Keywords: hepatitis c (hcv) infection transmission, maternal-fetal placenta trophoblast
surgery or capsular distention with steroid in the treatment of primary frozen shoulder?

Conditions: Adhesive Capsulitis

Summary: the purpose of the study is to compare two different treatment regimens for primary frozen shoulder: arthroscopic capsulotomy and arthrographic distention with steroid.

patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.

Eligibility criteria:
inclusion criteria: 1. the patient must have understood all information about the project and must have signed the informed consent letter about participation in the study including rehabilitation and follow-up 2. the patients must have a history and clinical findings typical for primary frozen shoulder with globally reduced range of motion in the shoulder. * external rotation 20 degrees or less * abduction 45 degrees or less 3. the patients must not be in phase 1 (inflammation phase) 4. diabetics may be included 5. mri must be taken to exclude other reasons for stiffness exclusion criteria: 1. other reasons for stiffness( cuff rupture, arthritis) 2. posttraumatic or postoperative stiffness 3. patients not suited for day surgery 4. patients with a history of subacromial impingement before developing stiffness

Keywords: randomized study capsulotomy vs distention with steroid
study evaluating the efficacy and safety of pantoprazole in infants with symptomatic gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux

Summary: to assess the efficacy of pantoprazole for the treatment of infants with symptomatic gastroesophageal reflux disease (gerd).


Eligibility criteria:
inclusion criteria: * term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months * clinical diagnosis of gerd * weight greater than 2.5 kg and less than or equal to 15 kg exclusion criteria: * known history of upper gi anatomic disorders * history of acute life-threatening medical conditions * clinically significant medical conditions or laboratory abnormalities

Keywords: gerd infants gastroesophageal reflux
does pulmonary daoyin of china give additional benefit over usual therapy in management of stable chronic obstructive pulmonary disease?

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to compare the exercise capacity and pulmonary function test parameters of chronic obstructive pulmonary disease (copd) patients who underwent usual care with and without pulmonary daoyin therapy of china in community.

this is a multicenter, randomized, none-blind, controlled study to evaluate the effect of pulmonary daoyin therapy in moderate to very severe copd subjects. following a 14 day run-in period, approximately 464 subjects will be randomly assigned to none-blind treatment for 3 months. the primary measure of efficacy is the exercise capacity (6mwd) and spirometric values (e.g. fev1). secondary efficacy measures include dyspnea (mmrc), quality of life (cat,sf-36), frequency of exacerbations. safety will be assessed through the collection of adverse events. there will be a total of 4 study visits (randomization, and after 1,2,3 months of treatment).

Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of moderate to very severe copd. * age between 40 and 80 years. * without participation in other interventional trials in the previous one month. * with the informed consent signed. exclusion criteria: * patients with poor mobility that can not do the exercise, i.e. wheelchair bound. * pregnant or breast-feeding women. * resting pulmonary artery pressure \> 45mmhg. * any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study. * patients with severe comorbidities, including acute myocardial infarction and unstable angina pectoris. * patients with post exercise syncope and osteoarthrosis that affect movement. * complicated with severe heart failure (class ii to iv nyha heart function). * complicated with bronchial asthma, bronchiectasis or active tuberculosis; * complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis， * complicated with pneumothorax, pleural effusion or pulmonary embolism. * complicated with neuromuscular disorder which affects the respiration. * complicated with tumors . * complicated with serious hepatic and renal diseases. * long periods of bed rest . * participating in other trials or allergic to the used medicine.

Keywords: pulmonary disease, chronic obstructive adult therapeutic use humans treatment outcome daoyin therapy
a program to increase sickle cell trait knowledge among parent of young children identified in newborn screening

Conditions: Sickle Cell Trait

Summary: this is a study for parents of young children with sickle cell trait (sct) identified by newborn screening who are referred and present for in person sct education at the institution. the study will determine the feasibility of implementing a sct education program (sctaware) that is appropriate for all parents, including those with low base knowledge and low health literacy and then test if results in high and sustained sct knowledge.

this is a single center, observational study to develop an education program for parents of young children diagnosed with sickle cell trait. this will be accomplish by evaluating the current ohio education in-person program, and assessing, through a set of questionnaires, how much participants are understanding about this diagnosis. during phase i of the study, participants will be video-taped, and a set of questionnaires will be answer before and after education is given. this data will then be analyzed by the sct team in order to develop the program. during phase ii of the study, population with the same criteria as phase i will be enrolled, however they will receive the revised "sctaware" education. pre and post education questionnaires will also be answered. in addition, participants during this phase will receive follow-up calls at 1 and 6 months to complete additional surveys. in addition, the investigators will be using the decisional conflict scale (dcs) to explore if parents experience decisional conflict about whether or not to obtain sct testing and if sctaware reduces this conflict

Eligibility criteria:
inclusion criteria: 1. adult biological parents of children \<3 years old with hemoglobin s-trait identified by nbs who present for sct education at nch. 2. english proficiency will be required exclusion criteria: 1. parents who self-report that they do not have functional verbal english (report that they are not proficient) or if they request an interpreter for the education session. 2. parents who have previously attended an education session about an abnormal hemoglobinopathy trait 3. parents who self-report that they have a child with scd 4. parents who self-report that they have scd. 5. parents who report that they or their partner is currently pregnant

Keywords: sickle cell trait education
use sonography in patients with intrauterine device presenting with bleeding

Conditions: Contraception

Summary: intrauterine contraceptive device is one of the most efficient and reversible methods of birth control with low cost and long duration of use however, in the first year after insertion, between 5 and 15% of women will have their intrauterine contraceptive device removed because of irregular uterine bleeding which have been attributed to the effect of contact between the device and the endometrium and even the pressure on the uterine muscle . the disharmonious relationship between the intrauterine contraceptive device and the uterus is the cause of most of the bleeding complaints, so bleeding is related to improper position rather than the contraceptive method itself which should be excluded before abandoning the intrauterine contraceptive device for any other method of birth control


Eligibility criteria:
inclusion criteria: patients using intrauterine contraceptive device complaining of bleeding exclusion criteria: * a-associated uterine, cervical,or adenexal pathology b-associated pelvic infection c-generalized bleeding disorders d-medications causing coagulation defects e-medical disorders causing bleeding e.g hypertention f-endocrine disorder as thyroid dysfunction g-who refuse to share in the study